Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A
Department of Medical Chemistry, University of Helsinki, Finland.
Contraception. 1992 Jan;45(1):49-55. doi: 10.1016/0010-7824(92)90140-o.
A new modified subdermal implant releasing the potent progestin ST-1435 was studied in eleven fertile-aged women. These implants have been developed for contraception and they have a life-time of two years. Three implant lengths of 4, 6 and 8 cm were tested to find the optimal steroid dose for inhibition of ovulation. Serum samples were collected twice per week during a six-week period every six months. The concentrations of serum ST-1435, estradiol and progesterone were determined by RIA. Ovulation was inhibited by all ST-1435 doses tested. The concentration of serum progesterone was below 6 nmol/l in all samples tested showing the absence of luteinization. The concentration of serum ST-1435 increased with increasing ST-1435 dose. Serum estradiol concentrations were quite variable, showing wide range and occasional high peak values typical of progestin treatment; the mean value of serum estradiol concentrations measured did not differ with different ST-1435 doses. The results of steroid determinations led to the conclusion that a single 4 cm subdermal implant is optimal for contraception. With this dosage level, ovulation is inhibited and side effects are minimized. Bleeding control was variable. No hormonal side effects due to the progestin ST-1435 were reported. This method, using a single 4 cm subcutaneous implant releasing the progestin ST-1435 with a life-time of two years, represents a promising alternative for inhibition of ovulation and contraception.
在11名育龄妇女中对一种释放强效孕激素ST - 1435的新型改良皮下植入物进行了研究。这些植入物是为避孕而研发的，其有效期为两年。测试了三种长度分别为4厘米、6厘米和8厘米的植入物，以找出抑制排卵的最佳类固醇剂量。每六个月在为期六周的时间内每周采集两次血清样本。通过放射免疫分析法测定血清中ST - 1435、雌二醇和孕酮的浓度。所有测试的ST - 1435剂量均能抑制排卵。所有测试样本中的血清孕酮浓度均低于6纳摩尔/升，表明没有黄体化现象。血清ST - 1435的浓度随ST - 1435剂量的增加而升高。血清雌二醇浓度变化很大，呈现出孕激素治疗典型的广泛范围和偶尔的高峰值；所测血清雌二醇浓度的平均值在不同的ST - 1435剂量下没有差异。类固醇测定结果得出结论，单个4厘米的皮下植入物是避孕的最佳选择。在这个剂量水平下，排卵受到抑制，副作用最小化。出血控制情况不一。未报告因孕激素ST - 1435引起的激素副作用。这种方法使用单个4厘米的皮下植入物释放孕激素ST - 1435，有效期为两年，是抑制排卵和避孕的一种有前景的替代方法。
